WAI YUEN TONG MEDICINE CO., LTD.
⚠️ Moderate Risk
FEI: 3008432914 • Kowloon Bay, Kowloon • HONG KONG
FEI Number
3008432914
Location
Kowloon Bay, Kowloon
Country
HONG KONGAddress
9 Wai Yuen Tong Medicine Building, 9 Wang Kwong Road, Kowloon Bay, Kowloon, Hong Kong
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 3/11/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 5/29/2009 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is WAI YUEN TONG MEDICINE CO., LTD.'s FDA import refusal history?
WAI YUEN TONG MEDICINE CO., LTD. (FEI: 3008432914) has 3 FDA import refusal record(s) in our database, spanning from 5/29/2009 to 3/11/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. WAI YUEN TONG MEDICINE CO., LTD.'s FEI number is 3008432914.
What types of violations has WAI YUEN TONG MEDICINE CO., LTD. received?
WAI YUEN TONG MEDICINE CO., LTD. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about WAI YUEN TONG MEDICINE CO., LTD. come from?
All FDA import refusal data for WAI YUEN TONG MEDICINE CO., LTD. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.